480
Participants
Start Date
September 15, 2023
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2025
Erzhi Tiangui Granule
The Drug Manufacturing Unit of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine produced the EZTG granule.The EZTG was packaged as 3 g/bag, batch number 01-FZ032-03. The daily dose is equivalent to 15g of Ligustrum lucidum (Nv Zhen Zi),15g of Lotus japonicus (Han Lian Cao),15g of the fruit of Chinese wolfberry(Gou Qi Zi),15g of Cuscuta chinensis(Tu Si Zi), 15g of Radix Rehmanniae Preparata(Shu Di Huang),12g of Angelica sinensis(Dang Gui),12g of Paeonia lactiflora(Bai Shao),12g of Ligusticum wallichii(Chuan Xiong),12g of Rhizoma cyperi(Xiang Fu),and 9g of Radix Glycyrrhizae (Zhi Gan Cao).The placebo granule,which was Preparata mainly composed of dextrin, was made in a similar color and shape to EZTG.Placebo granules were packaged as 3g/bag, with the same package of the EZTG, batch number 01-FZ032-03-1. The EZTG or placebo was orally administered after being dissolved in water, 3g each time, 2 times a day.
Erzhi Tiangui Placebo
The placebo consisted mainly of yellow bean powder, starch, carbogen, molasses and could mimic the appearance, color and smell of Erzhi Tiangui granules, but without any active ingredients. Daily doses of placebo were delivered in the same packaging as Erzhi Tiangui granules.
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan
The 960th Hospital of the PLA Joint Logistics Support Force
UNKNOWN
First Affiliated Hospital of Wenzhou Medical University
OTHER
Shanxi Provincial Maternity and Children's Hospital
OTHER
Maternity and Child Health Care of Zaozhuang
UNKNOWN
Yantai Shan Hospital
UNKNOWN
Maternal and Child Health Care Hospital of Shandong Province
UNKNOWN
Hospital for Reproductive Medicine Affiliated to Shandong University
UNKNOWN
Chongqing Medical Center for Women and Children
OTHER
The Second Hospital of Hebei Medical University
OTHER
Shandong University of Traditional Chinese Medicine
OTHER